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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device hood, surgical
Product CodeFXY
Regulation Number 878.4040
Device Class 2


Premarket Reviews
ManufacturerDecision
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
THI TOTAL HEALTHCARE INNOVATION GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 1 1
2017 6 6
2018 1 1
2019 4 5
2020 1 1
2021 1 1
2022 2 2
2023 6 11
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Device Contamination with Chemical or Other Material 9 9
Delivered as Unsterile Product 5 10
Material Integrity Problem 4 5
Adverse Event Without Identified Device or Use Problem 2 2
Biofilm coating in Device 1 1
Break 1 1
Detachment Of Device Component 1 1
Material Puncture/Hole 1 1
Difficult to Remove 1 1
Out-Of-Box Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 9 10
No Clinical Signs, Symptoms or Conditions 8 11
No Known Impact Or Consequence To Patient 2 2
Insufficient Information 2 4
Burn, Thermal 1 1
Skin Irritation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 O&M HALYARD, INC. III Apr-02-2024
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